CSV
Structured validation
Documented IQ/OQ/PQ evidence, traceable requirements, and release discipline aligned to how QA and IT qualify systems.
Validation-ready eQMS for pharma, biotech and medical device teams
From Quality Records to Compliance Intelligence
Complere connects your quality records, actions, people, and evidence into one visible operating system—so you don't just pass audits, you understand and control quality in real time.
Validation-ready foundation
Connected traceability
Built for inspections
Records Actions People Evidence Real-time visibility Decision-ready control
Built for quality leaders who need control, visibility, and inspection confidence across regulated operations.
Designed for teams that cannot afford fragmented quality execution
- 21 CFR Part 11–friendly
- Immutable audit trails — database-enforced
- No hard deletion
- Regional data residency
Platform
Our Quality Modules And Their Capabilities
Connected quality modules spanning the full quality lifecycle—each with the core features that keep your system inspection-ready and practical for regulated teams.
Document Control
Control SOPs, forms, templates, and approvals without relying on shared drives.
- Always serve the one approved version, with routing by role
- Edit SOPs in desktop Word, Excel, and PowerPoint—no re-upload
- Controlled prints and download logging
- Structured metadata and folder governance
- Link documents to CAPA, training, and change
- Keep one approved source of truth
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
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CAPA Management
Plan the fix, get it signed, do the work, and keep the evidence that it worked.
- Raise corrective and preventive actions and link them to the quality event
- Get the plan signed before work starts
- Track each action to its due date
- Connect to documents, change and training
- Record an effectiveness check when your SOP calls for one
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
Explore CAPA Management
Audit Management
Plan internal, supplier, and site audits with evidence, findings, and follow-up in one flow.
- Run internal, supplier, and site audits from one calendar
- Capture and classify findings, then drive them to closure
- CAPA and document linkage
- Inspection confidence views
- Keep the audit program visible
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
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Training & Competency
Show who is trained on the procedure in use, who is late, and who approved it.
- Assign training by group, department, job or site
- Prove completion with online and offline evidence
- Late training shown on the dashboard
- Linked procedural change
- Explain role qualification clearly
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
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Change Control
Move proposed changes through impact assessment, approval, implementation, and verification.
- Move changes from request to approval without the email chase
- See the document and training impact before you approve
- Implementation evidence capture
- Connection to CAPA and risk
- See impact before execution
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
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Risk Assessments
Structure risk assessments across products, processes, and quality events with scored, traceable records.
- Score risks consistently on a defined, traceable matrix
- Weight severity, probability, and detectability per ICH Q9
- Link risks to CAPA, change, and audit findings
- Due dates, reminders and residual risk sign-off
- Inspection-ready risk history
ICH Q9
ISO 14971
FDA 21 CFR Part 11
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Quality Events
Capture, classify, and investigate quality events with e-signed closure.
- Root cause analysis with severity and status lifecycle
- E-signed closure on the ALCOA+ audit trail
- Turn-around-time tracking from intake to closure
ALCOA+
FDA 21 CFR Part 11
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Supplier Management
Qualification, approved-supplier list, receiving inspection, and SCAR — the purchasing-controls chain.
- Qualification and re-qualification with multi-role e-signature
- Approved Supplier List at site, material, scope, and validity grain
- Receiving inspection with signed disposition
- SCARs that promote once to CAPA
ISO 13485 §7.4
FDA 21 CFR Part 11
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Built for Regulatory Inspection Readiness
Every module includes built-in controls that support continuous compliance and defensible inspection readiness.
FDA 21 CFR Part 11
Electronic Signatures
ISO 13485 Aligned
EU GMP Annex 11
ALCOA+Data Integrity
GAMP 5Risk-Based Validation
CSASoftware Assurance
GxP CloudRegulatory Readiness
Validation-ready foundation
CSV and CSA — Without Overhead
Apply the right level of validation rigor based on risk—without slowing adoption.
CSA
Risk-based assurance
Focus testing on what matters for patient safety, product quality, and data integrity—while keeping records inspection-defensible.
RBAC
Controlled access and approvals by role, site, and function.
Audit trails
Time-stamped, immutable history for governed changes — database-enforced.
Version diffs
Before-and-after visibility for documents and critical records.
No deletion
Restore with audit context instead of silent data loss.
What Quality Teams Gain
When quality work runs in one connected system, owners, due dates, approvals and training records stop living in separate places.
CAPA and Deviation Resolution
Named owners, due dates and automatic reminders reduce time spent chasing open actions across email threads.
Document Approval and Release
Electronic signatures and a set approval order replace shared-drive handoffs.
Training Completion and Compliance
Automated assignments linked to document updates keep training records current and inspection-ready without manual tracking.
Purpose-Built for Regulated Industries
Whether you work in pharmaceutical manufacturing, biotech, medical devices or contract manufacturing, each page shows the regulations you work to and where the records sit in Complere.
Pharmaceutical Manufacturing
SOPs, deviations, CAPAs, change control and training on signed records you can show an inspector.
Explore pharmaceutical manufacturingBiotech
Process changes, SOP revisions, training and risk assessments on signed records while the process is still changing.
Explore biotechMedical Devices
Procedures, CAPAs, risk assessments, audits and supplier approvals on signed records you can show an auditor.
Explore medical devicesCMO / CDMO
Client audits, deviations, change control, training and supplier approval on signed records you can show a client or an inspector.
Explore CMO & CDMOBuilt by teams who have lived through inspections
Complere is shaped by people with direct experience in pharmaceutical quality operations, medical device compliance, and GxP validation — not generic enterprise software marketing.
Experience
30+ years combined regulated-industry experience
Across pharmaceutical manufacturing, biotech, medical devices, and life sciences quality operations — including inspection support, deviations, and validation programmes.
Community
ISPE, PDA, ASQ & GAMP-aligned practice
We engage with the same professional communities and guidance frameworks — GAMP 5, data integrity, and computerized systems — that quality and IT leaders use to qualify vendors.
Package
CSV + CSA validation pack included
VMP, URS, risk assessment, and IQ/OQ/PQ templates — plus the FDA risk-based assurance approach — ship with deployment, structured for regulated rollout, not sold as a separate line item.
Evidence
Find the evidence in one place
Open SOPs, training records, and CAPA chains from one system when an auditor or customer QA asks for evidence.
Rollout
Phased validation path
Structured IQ/OQ/PQ alignment with documented roles, plus support for release impact when the platform or configuration changes.
Collateral
Validation & compliance depth
Review the validation approach and Annex 11 validation playbook before your formal assessment.
Implementation
Your system is ready in minutes. Your scope sets the go-live date.
We set up your Complere environment in minutes. After that, the pace is yours. Start fresh, and your team can work in it in the first week. Bring past records or add more modules, and we plan the time with you at kick-off.
01
Start with the free pilot
Three months on all eight modules, with item counts capped, for up to 10 users, with sample or non-GxP records.
Step 1: Set Up & Agree
(First week)
We set up your evaluation environment and agree written success criteria with your team.
Includes:
- Environment set up
- Written success criteria
- Initial configuration
Step 2: Run & Check
(Through day 60)
Your team works through all eight modules, and we check progress against the criteria at day 60.
Includes:
- Workflow execution
- User training & enablement
- Day 60 check
Step 3: Review & Decide
(Day 90)
Review the results against your criteria and decide. Your environment moves to a paid plan, or we remove it after a recovery window.
Includes:
- Results against your criteria
- Decision at day 90
- Moved to a paid plan, or removed after a recovery window
02
The full governed path
Plan 60-90 days for all eight modules, with staged validation and ongoing expansion.
01
Discovery & Planning
Requirements assessment, process mapping, and first-scope planning.
2-3 weeks02
Configuration & Setup
Workflow setup, role configuration, and controlled deployment prep.
4-6 weeks03
Training & Validation
User enablement, qualification activities, and acceptance checks.
3-4 weeks04
Go-Live & Support
Production rollout, hypercare support, and staged expansion.
Ongoing
Free 3-month pilot
No licence fee. Pilot places are limited, so each pilot works directly with our senior team.
Start From Where You Are
Whether you are leaving paper processes, retiring spreadsheets, or replacing a legacy eQMS — Complere provides a clear path forward.
Paper to Digital
Retire paper SOPs and binders
Challenge: Signatures in binders, no version history, slow retrieval in audits.
Solution & outcome: Convert controlled documents, approvals, and training records to a governed digital workflow with a full audit trail.
Explore path
Spreadsheet Replacement
Move off Excel tracking
Challenge: Spreadsheets break under inspection—no controls, no trail, easy to overwrite.
Solution & outcome: Replace shared-drive spreadsheets with controlled CAPA, deviation, and change workflows—inspection-ready by design.
Explore path
Legacy Replacement
Replace legacy eQMS
Challenge: Expensive, hard-to-adopt platforms that teams work around instead of in.
Solution & outcome: Migrate with a phased cutover that preserves validation posture and inspection evidence.
Explore pathRelated Resources
Explore related modules, compliance topics, and guides to build a complete picture of your quality system.
See how Complere can bring your quality operations under control
Schedule a guided demo focused on your workflows and compliance requirements, or start with a free 3-month pilot.
See Complere in action
Request demo